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NCT Number: NCT05764538

DAOIB for the Treatment of Brain Fog

This is a 24-week open trial. We will enroll long-COVID patients with cognitive impairments. All patients will receive DAOIB for 24 weeks. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB treatment will be beneficial in improving the cognitive function, mood symptoms, global functioning and quality of life in long-COVID patients with cognitive impairments.

Recruiting

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Key information

Conditions

Long COVID COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

Location status: Recruiting

Location contact

Chieh-Hsin Lin, MD, PhD

CONTACT

[email protected]

886-7-7317123 ext. 8907

Chieh-Hsin Lin, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • "post-COVID-19 condition" defined by WHO (symptoms present at three months after SARS-CoV-2 infection and last for at least 2 months which cannot be explained by an alternative diagnosis)(Cabrera Martimbianco, Pacheco et al. 2021) and COVID-induced cognitive impairments
  • physically healthy and have all laboratory assessments (including urine/blood routine, biochemical tests, and electrocardiograph) within normal limits
  • have sufficient education to communicate effectively and are capable of completing the assessments of the study

Exclusion criteria

  • history of significant cerebrovascular disease
  • Hachinski Ischemic Score > 4
  • major neurological, psychiatric or medical conditions other than long COVID-induced cognitive impairments
  • memantine use (memantine is an NMDAR partial antagonist)
  • substance (including alcohol) abuse or dependence
  • delusion, hallucination or delirium symptoms
  • severe visual or hearing loss
  • inability to follow the protocol

Treatment and study plan

DAOIB

Drug

The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation

Primary outcomes

  1. Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24

    Time frame: week 0, 8, 16, 24

    Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)

Secondary outcomes

  1. Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24

    Time frame: week 8, 16, 24

    Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24

  2. Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24

    Time frame: week 0, 8, 16, 24

    The assessment appears to be a suitable instrument for evaluating activities of daily living in early-phase dementia. Its scores range from 0 (worst) to 78 (best)

  3. Change from baseline in Quality of life score at week 8, 16 and 24

    Time frame: week 0, 8, 16, 24

    Quality of life will be assessed by Medical Outcomes Study Short-Form-36 (SF-36). The SF-36 consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health.

  4. Change from baseline of 17-item Hamilton Rating Scale for Depression

    Time frame: week 0, 8, 16, 24

    Assessment of depressive symptoms. The 17-item Hamilton Rating Scale for Depression will be measured every 8 weeks

  5. Change from baseline of Hamilton Anxiety Rating Scale

    Time frame: week 0, 8, 16, 24

    Assessment of anxiety symptoms. The Hamilton Anxiety Rating Scale will be measured every 8 weeks

  6. Change from baseline of Perceived Stress Scale

    Time frame: week 0, 8, 16, 24

    Assessment of stress and anxiety symptoms. The Perceived Stress Scale will be measured every 8 weeks

  7. Change from baseline in the score of a battery of additional cognitive tests

    Time frame: week 0, 8, 16, 24

    The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (Wechsler Memory Scale, Spatial Span), verbal/nonverbal learning and memory tests (Wechsler Memory Scale, Word Listing)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

DAOIB for the Treatment of Cognitive Impairment Induced by COVID-19 -An Open Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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